February 2014 page 1 of14

Medical devices – adverse incidents reported to MHRA in 2011 and 2012 This summary of 2011 and 2012 medical device adverse incident data replaces the annual reports that we have previously published. Data for 2013 will be added as soon as our review and validation is complete. Further changes are planned for both the content and format of future published data. Those changes will reflect substantial redevelopment of our adverse incident handling processes and, in particular, an expanded approach to continuing incident surveillance and trend analysis. The parallel introduction of new adverse incident data management tools will also allow us to publish updated core data more frequently. These data will be accompanied by thematic and trend reports on particular device types and on identified problem areas. Periodic Summary Reports (PSRs) PSR agreements between manufacturers and Competent Authorities (such as the MHRA) allow the manufacturer to combine in a single report, similar adverse incidents with the same device or device type, where the root cause is already known or where a Field Safety Corrective Action(FSCA) has already been implemented. This is much more efficient for both parties as many adverse incidents can be addressed in a single summary document.

Medical devices – adverse incidents reported to MHRA in 2011 and 2012

MHRA February 2014 page 2 of 14

Figure 1 Numbers of adverse incident reports 2011 and 2012

Table 1 Adverse incident reports and periodic summary reports (PSR)

2011 2012 Incident reports received 10,984 13,549

PSRs received 106 130

Individual incidents reported within PSR, including reports from clinical investigations

10,745 6,502

Total incidents reported – includes PSR 21,729 20,051

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Medical devices – adverse incidents reported to MHRA in 2011 and 2012

MHRA February 2014 page 3 of 14

Figure 2 Sources of reports

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Medical devices – adverse incidents reported to MHRA in 2011 and 2012

MHRA February 2014 page 4 of 14

Table 2 Types of reports received

2011 2012

Description of reports or action taken Number of reports % Number of

reports %

Reported as involving a fatality 294 2.7 303 2.2

Reported as involving a serious injury (including implant or pacemaker revision)

2,941 26.8 4,495 33.2

Prompted MHRA led investigations 1,598 14.5 2,001 14.8

Investigated by manufacturers under MHRA supervision 3,648 33.2 4,694 34.6

Not requiring immediate MHRA action. Recorded on database for trend monitoring and pattern detection

4,158 37.9 5,704 42.1

Reports of incidents similar to those already received by the MHRA 662 6.0 625 4.6

Reports from secondary sources, duplicating existing reports 704 6.4 696 5.1

Reports not relating to medical devices 148 1.3 185 1.4

Reports investigated by other organisations and their conclusion made available to the MHRA*

45 0.4 58 0.4

* Incidents reported via the Surgical Materials Testing Laboratory in Wales are no longer included in this category. Fatalities and serious injuries: reported compared to actual For incident investigations completed in 2012: • 305 incidents were reported as involving a fatality. In 194 cases (64%) the investigation did

not establish a link between that fatality and the device(s) involved in the incidents. • 4,417 incidents were reported as involving a serious injury. In 1,230 cases (28%) the

investigation did not establish a link between that injury and the device(s) involved in the incidents.

Medical devices – adverse incidents reported to MHRA in 2011 and 2012

MHRA February 2014 page 5 of 14

Figure 3 Online reports as a percentage if reports received from medical device users and from manufacturers In 2012 the proportion of user reports submitted online rose to almost 90%. The percentage of manufacturer reports submitted via MORE (Manufacturers Online Reporting Environment) has remained relatively stable over recent years. It is anticipated that the continued development of MORE, the use of XML, and the introduction of PDF forms with XML format data extraction capabilities will prompt considerable growth in this area.

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Medical devices – adverse incidents reported to MHRA in 2011 and 2012

MHRA February 2014 page 6 of 14

Figure 4 Devices involved in adverse incident reports The device groupings shown below cover over 95% of adverse incident reports received by MHRA. Certain device types do not fit into any of these categories, so are not included in this chart. The data are not directly comparable with similar charts produced in previous years. These figures do not include reports submitted within PSRs.

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Laboratory equipment

Gloves and barrier contraceptives

Dental devices

Obstetric, gynaecology and urology implants

Decontamination and sterilisation

Ophthalmic implants

Closure Devices

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Plastic, cosmetic and reconstructive surgery implants

Fluid management (non-vascular)

Anaesthetic and respiratory

Non-active cardiovascular implants

Orthopaedic implants

Diagnostic imaging & radiotherapy

In-vitro diagnostic devices

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Assistive Technology

Fluid management (vascular)

Surgical & patient monitoring

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Medical devices – adverse incidents reported to MHRA in 2011 and 2012

MHRA February 2014 page 7 of 14

Figure 5 Reported event type – Broad level ISO/TS 19218-1 event types for reported adverse incidents In April 2011, the MHRA started to use the international standard ISO/TS 19218-1:2011 ‘Medical devices - Hierarchical coding structure for adverse events - Part 1: Event-type codes’ when recording incident reports in our AITS database. The data below are from reports submitted to the MHRA in 2012 only. TS19218-1 specifies requirements for a hierarchical coding structure for describing adverse events relating to medical devices. The codes are intended primarily for use by medical device manufacturers and regulatory authorities to facilitate collecting and exchanging information.

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Medical devices – adverse incidents reported to MHRA in 2011 and 2012

MHRA February 2014 page 8 of 14

Figure 6 Reported event type – Detailed level: ISO/TS 19218-1 event types for reported adverse incidents The chart below shows the terms that were used on 100 or more occasions from January to December 2012.

In addition to the above, the term ‘other’ was also used and a number of further terms (see Table 3) were used on fewer than 100 occasions.

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Medical devices – adverse incidents reported to MHRA in 2011 and 2012

MHRA February 2014 page 9 of 14

Table 3 Event type categories from ISO/TS 19218-1 used on fewer than 100 occasions

Event type 2011 2012 Event type 2011 2012 [2301] Other 1218 2225 [2802] Failure to adhere or bond 15 34 [1805] Excessive Flow or Overinfusion 75 91 [2004] Material Discolored 26 28 [2502] Delivered as Unsterile Product 70 90 [1004] Premature Activation 17 26 [2705] Overheat of Device or Device Component 58 89 [2701] Burned Device or Component 14 24 [2601] Device Alarm System Issue 82 80 [1701] Component or Accessory Incompatibility 27 22 [2803] Misassembled 40 72 [1504] Loss of Power 12 15 [1804] No Flow 78 70 [1405] Spark 16 14 [1305] Loose or Intermittent Connection 43 68 [1401] Arcing 13 14 [1801] Deflation Issue 56 61 [2902] Inadequate Training 12 14 [2501] Damage Prior to Use 48 57 [2201] Chemical Issue 6 14 [1003] Failure to Separate 25 56 [2706] Smoking 5 14 [1803] Inflation Issue 33 52 [2702] Fire 11 12 [2906] Device Inoperable 20 52 [2903] Maintenance Issue 14 11 [1302] Disconnection 57 48 [2205] Telemetry Discrepancy 20 9 [2006] Material Perforation 48 48 [2203] Installation-Related 6 8 [2901] Inadequate or Inappropriate Disinfection or Sterilization 40 48 [1005] Delayed Activation 8 6 [1304] Fitting Problem 60 46 [1306] Misconnection 5 6 [2504] Item Contaminated during Shipping 31 43 [1303] Failure to Disconnect 14 5 [1602] Osseo-disintegration Issue 13 38 [2804] Therapy delivered to incorrect body area 5 5 [2101] Calibration 26 37 [1501] Environmental Particulates 2 5

[2106] Retraction Problem 30 35 [2505] Difficult to Open or Remove Packaging Material 4 4

[1101] Hardware Issue 22 35 [2704] Insufficient Cooling 5 3 [2801] Device displays incorrect message 18 35 [1102] Network Issue 4 3 [2204] Optical Issue 39 34 [2703] Flare or Flash 2 3 [2202] Communication or Transmission Level 32 34 [2904] Refurbishing Issue 1 3 [2802] Failure to adhere or bond 15 34 [1502] Fumes or Vapors 3 2 [2004] Material Discolored 26 28 [1503] Inadequate Storage 5 1

Medical devices – adverse incidents reported to MHRA in 2011 and 2012

MHRA February 2014 page 10 of 14

Figure 7 Triage decisions and investigation levels The current adverse incident handling system was implemented on 01 April 2011. The charts below illustrate the immediate impact of the new triage arrangements and the consequent incident investigation levels. The new process was designed to enable us to focus our medical device specialist resources directly on those issues which present the greatest risk to patient safety, and where our active intervention will make a positive difference to the resolution of the problem. The significant change in the proportion of reports being recorded for trending and surveillance purposes only (when compared to the former ‘Information only’ category) shows the immediate impact of the changes. This has, as intended, released our specialist resources for better focus on those incident reports that we do actively investigate.

* ‘Knowns’, ‘echoes’, non-MHRA investigations and reports not concerning medical devices

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Medical devices – adverse incidents reported to MHRA in 2011 and 2012

MHRA February 2014 page 11 of 14

Figure 8 Causes of adverse incidents The MHRA’s Adverse Incident Tracking System (AITS) incorporates multiple levels of categorised, contributory causal factors that are used in the record of each incident investigation. The first level provides the three options shown below. • Healthcare establishment/user responsibility: After delivery e.g. maintenance failures or degradation due to storage outside specification. • Manufacturer responsibility: Before delivery e.g. design, manufacture, quality control and packaging. • No established device/use link: Mostly where the device involved was not available for investigation but also where the device was subsequently found to work as intended.

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Medical devices – adverse incidents reported to MHRA in 2011 and 2012

MHRA February 2014 page 12 of 14

Figure 9 Investigation outcomes – investigations concluded Outcomes are recorded at the conclusion of an adverse incident investigation. These categories are not mutually exclusive: more than one may be selected for each concluded investigation. NOTE: Outcomes data presented in past reports were collated against different categories. The data in this chart are not, therefore, directly comparable with previously published data.

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Medical devices – adverse incidents reported to MHRA in 2011 and 2012

MHRA February 2014 page 13 of 14

Table 3 Safety warnings issued and received Medical Device Alerts (MDAs) are the MHRA’s prime means of communicating safety information to medical device users in health and social care. In circumstances where the target audience for such safety information is small (usually 10 or fewer recipients) a Targeted Letter is produced instead of an MDA. Targeted Letters are sent directly to the identified audience rather than being broadcast to the standard, much wider list of MDA recipients. Competent authority (CA) notifications are issued under the Medical Devices Regulations between the competent authorities of the European Union member states. In many cases they are also circulated more widely to member countries of the International Medical Device Regulators Forum (formerly the Global Harmonisation Task Force).

2011

2012

Medical Device Alerts

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84

Targeted Letters

20

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Competent authority notification: sent

157

255

Competent authority notification: received (from EU)

518

505

Medical devices – adverse incidents reported to MHRA in 2011 and 2012

MHRA February 2014 page 14 of 14

Figure 10 Time taken for conclusion of investigations The length of time taken for completion of an investigation will vary according to a number of factors. These include:

• the complexity of the research and analysis undertaken • the range of people that we need to contact • the number of devices involved in the incident, and their location • testing of the device by the manufacturer or by independent experts • police or coroner involvement, or other legal action.

Figure 10 shows the number of weeks taken for conclusion of 50% and 75% of specialist and ‘monitored’ investigations.

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